Inside Health

States, Bridling At Insulin's Cost, Push for Generics

By STEPHANIE SAUL

Published: January 11, 2007

As they examine their state health care budgets, 11 of the nation's governors have identified one big-ticket item they think should cost less: insulin.

The drug cost state Medicaid programs $500 million in 2005. And in the face of an epidemic of diabetes, the governors are asking why there is no cheaper generic version of a drug that, in one form or another, has been used since the 1920s.

Rose McDaniels is wondering, too. She is a bakery worker in Mississippi, the state with the highest incidence of the disease. The $115 a month she spends on insulin consumes more than 10 percent of her income.

She sometimes cuts back her dosage to make it from payday to payday, though she knows the risks. "I'm trying to make it until the next available dollar I can spare,'' she said.

The issue involves questions of politics and profits, as well as science.

Insulin is caught in a commercial tug of war between brand-name drug companies that want to protect their franchises and generic drug makers that want to produce their own insulin products. Recently, each side has stepped up efforts to advance its side of the argument, and there are signs that Congress is ready to make life easier for generic drug companies.

People with diabetes in this country, as well as government and private insurers, spend a combined $3.3 billion a year on insulin. Analysts say the price of insulin might drop by 25 percent if generic versions became available.

Now, as the nation's diabetes rate climbs, political pressure is mounting on the Food and Drug Administration to open the door to generic versions. And Gov. Haley Barbour of Mississippi, a Republican, and 10 other governors have asked the F.D.A. to ease the way for generic insulin.

''To have a lower-cost solution for our very large diabetic population is in the interest of the state and the interest of these people,'' Governor Barbour said.

In Congress, some members see the generic-insulin issue as having implications for the nation's health care bill that go well beyond diabetes treatments. Insulin is one of the most widely used of a growing category of drugs known as biologics -- medicines, made from living organisms, that are the fastest-growing segment of pharmaceutical spending.

Many believe that if generic insulin is approved, that would open the door to development of generic versions of other, more complex biologics. Some include popular and expensive treatments for rheumatoid arthritis, cancer and other diseases that cost tens of thousands of dollars a year. The colorectal cancer drug Avastin, for example, costs $4,000 a month.

Some generic drug manufacturers say that a first step would be for the F.D.A. to adopt guidelines explaining the testing and documentation that would be required for the approval of insulin. The 11 governors from states with high Medicaid spending on insulin are pressing for such guidelines, and generic drug manufacturers say they need them to proceed with applications for insulin.

But the issue has been clouded by a series of regulatory delays by the F.D.A. The agency announced in 2001 that it was developing guidelines for approving generic insulin and human growth hormone, another widely used and long available biologic. Those guidelines have never been released, however, partly, critics say, because of pressure from the Biotechnology Industry Organization, which represents the brand-name makers of biologic drugs.

The association argues that the same shortcuts to approval that are granted for conventional generic drugs are not applicable to biologics, even simple ones like insulin. Those shortcuts include an exemption from the long clinical testing required for approval of brand-name drugs. The trade group has been working to make sure generic drug companies cannot piggyback on the clinical studies done by drug innovators.

The F.D.A. says that it is studying the issue, but believes that it is more appropriate to develop guidelines that would apply to all biologics rather than to issue guidelines for individual products like insulin and human growth hormone. The agency has said it will release a scientific background paper this spring that examines the issue.

But Senator Orrin Hatch, a Utah Republican, and Representative Henry Waxman, a California Democrat, asked last year why the guidelines for insulin and human growth hormone had not been released. ''There is simply no excuse -- scientific, legal or otherwise -- for the F.D.A. to delay the release of these guidelines,'' the lawmakers said in a letter to the F.D.A.

As Congress looks for ways to reduce health care spending and broaden access to drugs, Mr. Waxman, who heads the House Oversight and Government Reform Committee, has said that legislation encouraging the development of generic biologics is one of his top priorities.

Generic versions of conventional drugs typically reach the market soon after the 20-year patents have expired on the brand-name medicines they mimic. All the drug maker needs to demonstrate is that the generic version contains the same active ingredients, purity and quality, and provides ''bioequivalence'' -- meaning it produces the same level of drug in the blood over time as the brand-name version. Long studies to prove safety and efficacy, which the brand-name manufacturers conduct to bring new drugs to market, are not necessary for the generic versions.